Z-1453-2018Class II

SOMATOM Sensation 10 Intended to produce cross-sections images of the body by computer reconstruction of...

Name: Z-1453-2018 SOMATOM Sensation 10 Intended to produce cross-sections images of the body by computer reconstruction of...
Creator: Siemens Medical Solutions USA, Inc
Published: 2018-02-15
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2018-02-15 / Terminated / root cause: software

FDA source

Siemens Medical Solutions USA, Inc began a recall of SOMATOM Sensation 10 Intended to produce cross-sections images of the body by computer reconstruction of x-ray transmission data on 2018-02-15. FDA classified it as Class II and gives the reason as "to inform customers of possible incorrect tube current calculations by the CARE Dose4D algorithm for head scans based on p.a. (posterior-anterior) or a.p. (anterior-posterior) topograms. Depending on the geometrical...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-1453-2018
Classification: Class II
Status: Terminated
Initiated: 2018-02-15
Posted: 2018-04-30
Terminated: 2020-04-08
Recalling firm: Siemens Medical Solutions USA, Inc.
Product: SOMATOM Sensation 10 Intended to produce cross-sections images of the body by computer reconstruction of x-ray transmission data.
Product code: JAK System, X-Ray, Tomography, Computed
Reason for recall: to inform customers of possible incorrect tube current calculations by the CARE Dose4D algorithm for head scans based on p.a. (posterior-anterior) or a.p. (anterior-posterior) topograms. Depending on the geometrical shape of the skull bone, it may happen in rare cases that the calculated dose distribution is not appropriate and could lead to unnecessary radiation exposure
Root cause tag: software
FDA root cause: Software design
Action: The Center for Devices and Radiological Health (CDRH) understands that the CAP involving 1301 units will consist of the following: 1. You will contact customers and initiate the actions to correct the failure to comply issue. 2. You will provide a software update to correct tube current calculations by the CARE Dose4D algorithm for head scans. 3. You will follow-up with consignees to verify the effectiveness of the software update. CDRH approves the CAP subject to the following conditions: 1.Notification of all dealers and purchasers is to be made within 15 working days of receipt of this letter in the manner specified in 21 CFR 1003.21 and 1003.22. This office and the Food and Drug Administration (FDA) district office coordinator noted below are to be included in the notification. 2. Any future customer notification letters to be sent must comply with the requirements of 21 CFR 1003.21. This includes, but is not limited to, the prescribed packaging and the statement that you will remedy the defect or bring the product into compliance at no charge. You may proceed or continue with implementation of the CAP (subject to the conditions noted above). For further questions, please call (610) 219-4834.
Quantity in commerce: 1301
Distribution: USA (nationally) Distribution.
Product codes and lots: 7543015

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1453-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1445-2018	Class II	Terminated	Voluntary: Firm initiated	2018-05-09	2018-04-30
Z-1446-2018	Class II	Terminated	Voluntary: Firm initiated	2018-05-09	2018-04-30
Z-1447-2018	Class II	Terminated	Voluntary: Firm initiated	2018-05-09	2018-04-30
Z-1448-2018	Class II	Terminated	Voluntary: Firm initiated	2018-05-09	2018-04-30
Z-1449-2018	Class II	Terminated	Voluntary: Firm initiated	2018-05-09	2018-04-30
Z-1450-2018	Class II	Terminated	Voluntary: Firm initiated	2018-05-09	2018-04-30
Z-1451-2018	Class II	Terminated	Voluntary: Firm initiated	2018-05-09	2018-04-30
Z-1452-2018	Class II	Terminated	Voluntary: Firm initiated	2018-05-09	2018-04-30
Z-1453-2018	Class II	Terminated	Voluntary: Firm initiated	2018-05-09	2018-04-30
Z-1454-2018	Class II	Terminated	Voluntary: Firm initiated	2018-05-09	2018-04-30
Z-1455-2018	Class II	Terminated	Voluntary: Firm initiated	2018-05-09	2018-04-30
Z-1456-2018	Class II	Terminated	Voluntary: Firm initiated	2018-05-09	2018-04-30
Z-1457-2018	Class II	Terminated	Voluntary: Firm initiated	2018-05-09	2018-04-30
Z-1458-2018	Class II	Terminated	Voluntary: Firm initiated	2018-05-09	2018-04-30
Z-1459-2018	Class II	Terminated	Voluntary: Firm initiated	2018-05-09	2018-04-30

Product code JAK

K050297Class IISomatom Emotion 16Siemens Medical Solution, Inc. USA / cleared 2005-03-01

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)